Vaccine Stabilization via Freeze-Drying Glassy Matrix
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Solution Overview
Problem
Current methods for stabilizing adjuvant-containing vaccine compositions, particularly influenza vaccines, face challenges in maintaining the stability and potency of antigens and adjuvants during storage, especially when in liquid form, as interactions between them can lead to instability and reduced effectiveness.
Innovation Solution
A process involving the formation of dry regular spherical micropellets or particles by diluting the vaccine composition with a stabilizer, freezing, and then freeze-drying to create a glassy matrix that traps antigens and adjuvants, thereby maintaining their stability and interaction potency during storage.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If the vaccine composition is stored in liquid form, then it maintains its biological activity, but the interactions between antigens and adjuvants lead to instability and reduced effectiveness over time
Solution Approach 1:
The patent applies parameter changes by transitioning the vaccine composition from liquid to frozen state, and then to freeze-dried solid form. This phase change fundamentally alters the stability parameters, preventing antigen-adjuvant interactions that occur in liquid form while maintaining biological activity through controlled freezing and freeze-drying processes
Solution Approach 2:
The patent creates a composite stabilized composition containing antigens, adjuvants, and stabilizing agents (such as sugars, proteins, or other excipients) that work together to maintain stability. The composite structure protects both antigen and adjuvant components during storage, allowing long-term stability without requiring continuous refrigeration
2Temperature
If the vaccine composition is freeze-dried to improve stability, then storage conditions can be improved, but the process complexity increases
Solution Approach 1:
The patent applies preliminary action by incorporating stabilizing agents into the vaccine composition before the freeze-drying process. This pre-stabilization ensures that the antigens and adjuvants are protected during the phase transition and subsequent storage, simplifying the overall process by preventing degradation issues that would require additional complex steps
Solution Approach 2:
The freeze-drying process involves controlled parameter changes including temperature reduction during freezing, pressure reduction during drying, and moisture removal. These parameter changes transform the liquid composition into a stable solid form that can be stored at higher temperatures while maintaining vaccine efficacy
3Stability of the object's composition
If stabilizing agents are added to the vaccine composition, then the interaction stability between antigens and adjuvants is maintained, but the formulation complexity increases
Solution Approach 1:
The patent uses stabilizing agents as intermediary substances that mediate between the antigens and adjuvants. These agents (such as sugars, amino acids, or proteins) physically or chemically interact with both components to prevent direct antigen-adjuvant interactions that lead to instability, while maintaining the necessary biological activity of the vaccine
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
This method significantly enhances the stability and potency of vaccine compositions by standardizing antigen and adjuvant interactions upon rehydration, allowing for improved storage conditions, including higher temperatures, and maintaining the integrity of the vaccine components.
Implementation Method 1
subjecting the regular droplets to freezing in a freezing medium to form frozen regular spherical micropellets or particles and drying the frozen regular spherical micropellets or particles
Implementation Method 2
freezing, and then freeze-drying to create a glassy matrix that traps antigens and adjuvants
Implementation Method 3
subjecting the regular droplets to freezing in a freezing medium to form frozen regular spherical micropellets or particles
Data Source
AI summary
The present invention relates to a process for stabilizing an adjuvant containing vaccine composition, an adjuvanted vaccine composition in dry form and in particular a process for stabilizing an influenza vaccine composition, particularly an adjuvanted influenza vaccine composition in dry form.